Downstream Manager

Job Summary:

We are seeking a dedicated and detail-oriented QC Microbiologist with 2 to 4 years of experience in pharmaceutical/biotech microbiology labs. The ideal candidate will be responsible for performing microbiological testing to ensure compliance with GMP standards and regulatory requirements.

Key Responsibilities:

• Perform routine microbiological testing including:
• Sterility testing
• Water and air sampling
• Environmental monitoring (EM)
• Bioburden and endotoxin testing
• Identification of microorganisms
• Microbial limit tests
• Maintain microbiological data and logbooks.
• Participate in media fill validations and aseptic process simulations.
• Prepare and review SOPs, protocols, and reports related to microbiology activities.
• Ensure all testing and documentation complies with GMP, USP, EP, and regulatory guidelines.
• Support microbiological investigations (OOS, deviations, CAPAs).
• Operate and maintain laboratory instruments such as autoclaves, incubators, particle counters, etc.
• Coordinate with production, QA, and validation teams for sample planning and testing timelines.
• Assist in audits and regulatory inspections as needed.

Qualifications:

· B.Sc. / M.Sc. in Microbiology, Biotechnology, or related life science discipline.

· 2 to 4 years of hands-on experience in QC Microbiology within a regulated pharmaceutical or biotech environment.

· Knowledge of cGMP, GLP, and regulatory guidelines (FDA, EMA, WHO).

· Familiarity with microbiological techniques and cleanroom classifications.

· Good documentation practices and understanding of data integrity principles.

· Proficiency in MS Office and LIMS (Laboratory Information Management System) is a plus.

Job Type: Full-time

Pay: ₹300,000.00 - ₹800,000.00 per year

Benefits:

• Provident Fund

Ability to commute/relocate:

• Pondicherry, Puducherry: Reliably commute or planning to relocate before starting work (Required)

Experience:

• APIs: 5 years (Required)

Work Location: In person